Understanding US FDA Regulatory Affairs

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Course Overview


To place your pharmaceutical, biotech of advanced therapy on the US market you must first gain FDA regulatory approval. Like all regulatory agencies, the FDA process requires skill and knowledge to navigate efficiently and to ensure fast approval.


This FDA regulatory training course examines the processes, terminology and best practices to ensure your interactions with the FDA are positive. Once completed, you will have the confidence to successfully submit Investigational New Drug Applications (IND) and New Drug Applications (NDA). You will learn the practical regulatory skills to get your pharmaceutical or biotech approved by FDA reviewers. You will also learn how best to gain approval for generics and biosimilars.


With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.


What is included in a live online course?


Key Learning Objectives


  • Understand the FDA structure, history and terminology so you are better equipped to communicate and interact with reviewers
  • Gain practical skills to manage the FDA Investigational New Drug (INDs) process and ensure submission efficiency
  • Understand best practice to navigate the FDA Investigational New Drug Application (IND) process and ensure you have all the data needed
  • Examine the FDA regulatory processes and requirements for pharmaceuticals, biologics and advanced therapies
  • Gain top tips for interacting with the FDA to obtain information quickly and prevent submission delays
  • Learn best practice for getting a generic product approved, including biosimilars.
Post Learning Implementation Plan (PLIP)


  • Access to the Educo Training Portal
  • Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

  • At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

  • Delivered 3 to 4 weeks after the training
  • It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover and subsequent questions and challenges
Module 1
FREE to Attend

Sign up

| 60 mins

Overview of the US Food and Drug Administration (FDA)

  • The History of the FDA and Regulations
  • The FDA today
  • Review the FDA’s organisation by division
  • Examine the future direction of FDA
Module 2

| 120 mins

Examining the drug development regulations in the US

  • The drug development process in the US
  • Clinical trials and Investigational New Drug (INDs)
  • Discover who is involved in development and the types of INDs
  • Basic understanding of the IND content:
    • Analysing the manufacture of drug substance and
      drug product
    • Preclinical testing requirements
    • Clinical testing requirements
Module 3

| 120 mins

Reviewing the Investigational New Drug Application (IND) process and requirements

  • Defining the regulatory requirements for submitting an IND
  • Discuss the FDA review process for INDs
  • Maintaining active INDs successfully
  • Understanding the obligations of the Sponsor
  • Reporting Adverse Events (AEs) – procedures
  • Defining other IND amendments
  • Preparing Annual Reports
Module 4

| 120 mins

Evaluation of FDA review options

Understanding the following FDA review options:

  • Fast track
  • Priority review
  • Accelerated review
  • Breakthrough status
  • OTAT and RMAT Process / Interact
Module 5

| 120 mins

Reviewing the New Drug Application (NDA) process

  • Defining full NDAs
  • Examining the NDA categories
  • Explaining abbreviated NDAs and 505 (b) (2)
  • Learn the requirements and processes for biologics and advanced therapies (Cell and Gene)
    • How to manage Biological and Biosimilars
    • Examining key differences against small molecules
    • Review CGT
  • The content overview
Module 6

| 120 mins

Examining generic submissions including biosimilars

  • Understand patent and exclusivity for Generics and Biosimilars
  • Review the legislative history and regulations for ANDAs
  • Opportunities for improvement and challenges
  • Examining Generic Drug User Fee Amendments (GDUFAs)
  • Managing launch activities including Pre-Launch Activities Importation Requests (PLAIR)
Module 7

| 120 mins

How does the FDA review and maintain a New Drug Application (NDA)?

  • Examine when there will be a refusal to file
  • Learn the requirements and processes for biologics and advanced therapies (Cell and Gene)
  • Clarifying the procedure from the receipt to the filing of
    the NDA
  • Discuss the interactions between the sponsor and FDA reviewer
  • When and how to conduct NDA amendments
  • Review strategies to maintain NDAs successfully
  • Scale-up and post approval changes
  • Examining annual reports
Module 8

| 120 mins

Interacting and obtaining information from the FDA

  • Review the various FDA meetings (Type A, B and C)
  • Discuss meetings on Biosimilars
  • Office of Tissues and Advanced Therapies (OTAT) meetings
  • The summary basis of approval
  • Advisory meetings
  • Discuss best practice for meetings with the FDA


Andrew Willis is a regulatory and Development consultant with 30 years of experience. Andrew’s management roles have seen him act as global Vice President of Regulatory Affairs and Medical Affairs, creating business for complex pharmaceutical development projects. Andrew has gained therapeutic experience in areas covering CNS, oncology, urology and pain management.


Experienced with both EU and US applications (NDA, 505 B 2, ANDA, BLA, MAA) for NCEs, generics and line extensions, with particular knowledge of sterile and biotech products. Andrew’s experience covers multiple applications, scientific advice meetings and orphan drug applications. He has significant experience with novel drug delivery systems has been utilized in all the above type of applications.


Andrew continues to provide training for all major companies and also a number of EU Member states agencies in CMC, variations and advanced regulatory affairs. He currently delivers extensive training courses on the EU and US, specifically looking at QbD, CMC regs and lifecycle management. Andrew has delivered multiple courses on FDA regulatory affairs, supporting professionals with their FDA submissions. He has delivered FDA regulatory courses on a range of products such as pharmaceuticals, biotech, cell and gene, generics and biosimilars.

This course is aimed at professionals who work in regulatory affairs and are involved in the approval of therapeutics in the US. These include: Regulatory Affairs Professionals | CMC Regulatory Professionals | Product Registration Personnel | Project Managers in Regulatory Affairs | Compliance Managers | Documentation Specialists | Quality Professionals and QPs.


Free First Module and Pricing
  • Module 1 is free to attend for this live online course and is delivered a few weeks before the start date.
  • To enrol onto module 1, please submit your email at the top of the page.
  • All sessions are recorded. If you are unable to attend module 1, you can catch up ahead of the course start date.
  • You will receive a Super Early Bird discount if you purchase the course before module 1.
  • If you decide to purchase the course after module 1, but before the start date you will receive an Early Bird Discount.
  • To sign up to the free first module provide your email address in the form at the top of the page

Frequently asked questions (FAQs)

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

Or please summarise your objectives by completing the form below.

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• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate.